2. Questions to the Cabinet Secretary for Health and Social Services – in the Senedd on 13 December 2017.
2. Will the Cabinet Secretary make a statement on the use of mesh implants in Wales? OAQ51465
In light of the significant concerns raised on this issue, I established a task and finish group to advise on any further action that should be taken within Wales on the use of mesh implants for the treatment of pelvic organ prolapse and incontinence. That group will report to me in January 2018.
Cabinet Secretary, the list of mesh implant survivors is growing every day and so is the campaign against its inappropriate use. New Zealand has effectively just ended the use of vaginal mesh implants and questions around consent are increasing all the time. Some people's bodies are rejecting this mesh in a very painful way, but they often are not given the proper chance to reject having the meshes fitted in the first place. Given the growing number of mesh implant survivors, England has adopted multidisciplinary teams of specialists who support patients who have had issues with mesh and advise them on treatments. Do these multidisciplinary teams exist in Wales and, if so, where are they? I'd specifically like that question answered. So, do multidisciplinary teams exist in Wales and where are they?
I'm happy to respond. This is an issue of significant public concern, and understandably so. I recognise perfectly well that there are a number of people who have had life-changing consequences from mesh implants. And it's important to recognise that, that it is a real issue. My interest is in understanding the exact scale of the challenge and what we could and should do about it.
I note what you said about the campaign against inappropriate use. Part of our challenge is that, actually, some people are campaigning for a total ban—a blanket ban—and others are saying that we need to understand how implants could or should be used, and what's appropriate. That's why the terms of reference that I gave the task and finish group were to look at current practice, to look at historic practice, and in particular one of the points was about fully informed consent. Because I really am concerned about a number of the stories that have come from people who've had mesh or tape implants that have gone wrong and whether they actually had a fully informed consent process. So, it's really important to understand what we're doing. Interestingly, there's been a significant reduction in mesh and tape implant use in these procedures in Wales.
My understanding is that, yes, we do have multidisciplinary teams around each surgical procedure. I think it's helpful to try and set out that before people get to the point of having surgery, they should already have had all other treatment options exhausted. It's not a first-line treatment; that does mean things like physiotherapy and other forms of therapy first. And, indeed, in the task and finish group, it is a multidisciplinary group. So, it's not just surgeons; there are physiotherapists and others on it. Those teams should exist wherever the surgery takes place. So, rather than saying, 'Where are they?', and trying to pinpoint locations, that depends on where the surgery took place. My interest, though, comes back to the regulator indicating whether or not these are appropriate devices for clinicians to use and then the appropriate professional advice about when they could and should be used; and, again, the role of politicians in endorsing clinical evidence and advice and not getting ahead of that. So, it's difficult.
I expect as part of the work to meet a number of people affected. I expect, as I've indicated, to receive the report in January. Whatever happens in Wales, we will take account of the National Institute for Health and Care Excellence guidance that is being revised, and I fully expect to meet the commitment that I've already given in this place, through the leader of the house, to provide a statement to Members. So, there is no doubt that this will continue to be an issue of significant concern to all of us around the Chamber.
This is a horrific story: a 10 per cent failure rate on average throughout the UK, and, my understanding is, throughout the world. One of the things that really concerns me is that these devices were allowed to be used because, although they had not been tested, they had gone through the medical devices process, under some sort of guidance-like similarity. I just wonder, Cabinet Secretary, whether you could produce a written statement to inform us how the medical devices guidelines work, and what process any medical device that would be inserted into our bodies—what the normal run rate, what the normal processes are. Because I do have a concern that this particular brand of tape—and there has been some questions in the past about the kind of tapes used to hold hernias in; some of those have been made of these highly synthetic materials, and have caused problems. So, I'd be really interested, and I think we'd all be really interested, in understanding how we allow these devices to be used, and what the guidelines, the processes, the procedures are for safeguards to make sure that we only let stuff that's been really well tested into our Welsh NHS.
When I provide the written statement—. I'm expecting the group to report to me in January and then to make a written statement after. So, when I do that, I'll make sure I cover the exact point that you raise. The task and finish group is actually looking at pelvic organ prolapse, as opposed to hernia operations. There'll be a different group of surgeons to be involved. But I know that some people have also raised concerns about hernia operations. And, interestingly, in the failure rate, it looks like that part of our challenge is in the data that we have, and understanding what the failure rate is, or the complication rate, in Wales. It looks like it's lesser; it looks like the surgical community in Wales didn't actually have the same enthusiasm for mesh and tape as other parts of the UK. But there is still a challenge around the UK, and let's not pretend that, somehow, there are no challenges here, because we understand there are. And I want to be as transparent as possible in setting out the advice that I will be giving, what will then take place afterwards, and to make sure that Members and constituents are properly informed. And I will, as I say, make sure your point about device testing is covered when we provide a statement in response.
Cabinet Secretary, I've raised the issue of pelvic mesh within the Welsh NHS in this Chamber previously. The issue was brought to my attention by a constituent of mine, who spoke to me about her heartbreaking experience. And my constituent is among thousands of other women, across the UK, who face the same life-changing circumstances. Now, this issue is receiving increasing publicity, and there was a Panorama programme on earlier this week, highlighting the suffering caused by these implants. And the investigation also suggested that doctors were unaware of the risk posed by mesh implants.
You mentioned the work of the task and finish group, and I look forward, as other Members will, to hear the progress on that. But what assurances can you give me, and my constituent, to ensure that women like her won't have to go through similar traumatic experiences because of mesh in the future?
I think it's important for me to be honest about what I can and can't do, and I can never guarantee to anyone that a surgical procedure won't go wrong. There is an inherent risk in invasive surgery that it may not work as you would wish it to and as most of the evidence suggests it should do. What matters even more so in this case is the consequences of that surgery going wrong, the life-changing impact, and whether there has been, as I say, a proper understanding of the risks that the operation presents in terms of benefits. Because most women who get to this point have actually got a life-changing challenge in the first place, but are still then properly understanding what risks are being borne, how and why, and whether there are better alternatives. So, the work of the task and finish group, the NICE guidance, will be really important for us to understand what is the best possible response for and from clinicians, what is the role of Government, and making something happen where that is not the role, but understanding whether the devices themselves continue to be available to clinicians, and in what circumstances as well. That's why I say I want to have clarity in providing an answer, when the report is provided to me, and to be utterly transparent with Members about what will and what won't happen. Because, as I say, I recognise it's had a significant, life-changing impact on a number of our constituents right across the country.